At the time of the audit, the FDA identified several concerns related to the preparation of equipment and resumption of production following a manufacturing shut-down event, as well as concerns related to the formulation of a specific customer product. According to an information sheet supplied by JHS, the company responded to the initial concerns following the April 2013 audit, but the FDA found deficiencies in the response and has asked for more clarification and to support manufacturing compliance through the warning letter.
A company statement read, "JHS CMO is actively forming a response to the FDA and is working toward a quick and agreeable resolution. Working with the FDA to ameliorate this situation in a thorough and timely manner is our number one priority."
JHS is required to respond to the letter by December 20, after which FDA will review the response and execute a followup audit to ensure compliance. If the FDA is satisfied with JHS' remediation of deficiencies, the Warning Letter will be lifted and the company will be able to resume its pre-audit activities. The Warning Letter does not impact the allergy business that operates in the Spokane facility.
In February 2013, JHS' site in Montreal (formerly Draxis), received a Warning Letter from FDA related mainly to quality sampling and release of out-of-spec products. JHS noted that the new Warning Letter will have no impact on the Montreal situation, which it expects to be resolved soon.